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Increased Drug ResistancePhase 2NSCLCNCT01718847

NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors

A Phase 2 study testing NOV120101 (Poziotinib) in people with Increased Drug Resistance, run by National OncoVenture at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Increased Drug Resistance
What is being tested?
NOV120101 (Poziotinib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesSouth Korea
Study dates
Jan 2013to Sep 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 20 years or older
  • Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarinoma
  • Patients who have 1 or more than 1 measurable or evaluable but unmeasurable lesions according to RECIST ver1.1
  • Patients who received prior 1st generation EGFR TKIs (gefitinib or erlotinib) monotherapy and meet the following criteria:
  • Patients with EGFR mutation (e.g., G719X, exon 19 deletion, L858R, L861Q, etc) known to be associated with sensitivity to TKIs
  • Patients who showed objective clinical benefit from treatment with an EGFR TKI as defined by either:
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  • Patients who showed complete (CR) or partial response (PR), or
  • Patients who maintained stable disease (SD) status ≥ 6 months
  • Patients who showed progressive disease (PD, RECIST ver1.1) while on continuous treatment with gefitinib or erlotinib within the last 30 days (However, patients whose progressive disease is limited in the brain cannot participate in this trial.)
  • No intervening systemic chemotherapy between cessation of the EGFR TKI and participation of this study
  • Patients who agree to the collection of tumor tissue specimen
  • ECOG performance status ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Adequate hematological, hepatic and renal functions:
  • WBC ≥ 4,000/mm3, Platelet ≥ 100,000/mm3, Serum creatinine ≤ 1.5 X ULN, AST and ALT ≤ 2.5 X ULN, Total bilirubin ≤ 1.5 X ULN
  • Patients who give written informed consent voluntarily

Who cannot join

  • Patients who receive IP within 3 days from prior treatment with gefitinib or erlotinib
  • NCI-CTCAE grade > 1 adverse events due to treatment with gefitinib or erlotinib
  • Prior systemic chemo, immuno, hormonal and/or biological therapy except gefitinib or erlotinib within 4 weeks before IP administration
  • Acquired resistance to EGFR TKI due to conversion of adenocarcinoma into small cell lung cancer
  • Patients who received major surgery within 4 weeks before IP administration
  • Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
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  • History of other malignancies except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for ≥ 3 years and considered to be cured by investigator's judgment
  • Known pre-existing interstitial lung disease (ILD)
  • NYHA class III or IV heart failure, uncontrolled hypertension, unstable angina or myocardial infarction within 6 months, poorly controlled arrhythmia or other clinically significant cardiovascular abnormalities at investigator's discretion
  • Patients whose left ventricle ejection fraction (LVEF) is below the institutional lower limit of normal (if no lower limit of normal is defined in the site, the lower limit is 50%.)
  • Patients with known active hepatitis B, HIV infection, or other uncontrolled infectious disease
  • Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption disorders, CTCAE grade ≥ 2 diarrhea due to any etiology)
  • Patients who cannot receive IP by mouth and be diagnosed with clinically significant gastrointestinal disorders which can prevent administration, transit or absorption of the IP
  • Pregnancy or breast-feeding
  • Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
  • Patients who received other investigational products except gefitinib and erlotinib within 4 weeks before participation
  • Patients who cannot participate in this trial by investigator's judgment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-711

  • Ulsan University Hospital

    Dong-gu, Ulsan, 682-714

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Asan Medical Center

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

About this study

Official title: Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) in Lung Adenocarcinoma Patients With Acquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors

The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).

Read the detailed description

Acquired resistance to prior EGFR TKIs is considered as "unmet medical need" in clinical practice. To evaluate the efficacy of NOV120101 (Poziotinib) as a second-line monotherapeutic agent, patients with acquired resistance to gefitinib or erlotinib will be enrolled in this study. Subjects will receive NOV120101 (Poziotinib) 16 mg PO once daily until disease progression or unacceptable toxicity development. Progression free survival (PFS) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 16 weeks, ORR and DCR will also be analyzed.

Being tested
NOV120101 (Poziotinib)
Keywords
EGFR Tyrosine Kinase Inhibitor, Aquired resistance to EGFR TKI, Pan-Her inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOV120101 (Poziotinib)Drug

    Also called HM781-36B

    16 mg PO once daily until disease progression or unacceptable toxicity development

Study groups in NCT01718847
Study groupRoleWhat they receive
NOV120101 (Poziotinib)Experimental16 mg PO once daily until disease progression or unacceptable toxicity development
Receives: Drug: NOV120101 (Poziotinib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    The length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.

    Measured: By 1 year after enrollment of the last subject

Secondary outcomes (9)

  1. PFS rate at 16 weeks

    The proportion of Patients maintaining progress-free status at 16 weeks

    Measured: 16 weeks

  2. Objective response rate (ORR)

    The proportion of patients with partial response or complete response at their best tumor treatment evaluation

    Measured: By 1 year after enrollment of the last subject

  3. Disease control rate (DCR)

    The proportion of patients with CR, PR and/or stable disease (SD)

    Measured: By 1 year after enrollment of the last subject

  4. Overall survival (OS)

    Measured: By 1 year after enrollment of the last subject

  5. Time to progression (TTP)

    Measured: By 1 year after enrollment of the last subject

  6. Time to objective response

    Measured: By 1 year after enrollment of the last subject

  7. Duration of objective response

    Measured: By 1 year after enrollment of the last subject

  8. Duration of disease control

    Measured: By 1 year after enrollment of the last subject

  9. Change of quality of life (QoL) measured by EQ-5D questionnaire

    Measured: baseline and the end of treatment, by 1 year after enrollment of the last subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718847
Sponsor's protocol ID
NOV120101-202
Acronym
NSCLC
Status last verified
Aug 2015
First submitted
22 Oct 2012
Last updated
14 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOV120101 (Poziotinib) in people with Increased Drug Resistance, run by National OncoVenture at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: By 1 year after enrollment of the last subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01718847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.

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